Swimming-Based Rehabilitation for Recovery After Thoracolumbar Spinal Fusion (AQUA-SPINE)
Structured Swimming-Based Rehabilitation Improves Functional Recovery After Thoracolumbar Spinal Fusion: A Prospective Comparative Observational Cohort Study
This study evaluates the effectiveness and safety of a structured swimming-based rehabilitation program in patients undergoing thoracolumbar spinal fusion. Postoperative rehabilitation after spinal fusion varies widely, and evidence supporting specific exercise strategies remains limited.
In this prospective observational cohort study, patients undergoing thoracolumbar spinal fusion are allocated to either a structured swimming-based rehabilitation program or a standard rehabilitation program. The swimming program is initiated 6 to 8 weeks after surgery and is performed three times per week for 12 weeks.
The primary outcome is the change in functional disability as measured by the Oswestry Disability Index at 12 weeks. Secondary outcomes include pain intensity assessed using the Visual Analog Scale and quality of life assessed using the Short Form-36 questionnaire.
The results of this study aim to determine whether structured aquatic exercise can improve functional recovery, reduce pain, and enhance quality of life following thoracolumbar spinal fusion.
調査の概要
詳細な説明
Thoracolumbar spinal fusion is commonly performed for degenerative, traumatic, and osteoporotic spinal conditions. Despite advances in surgical techniques, postoperative recovery remains heterogeneous, with many patients experiencing persistent pain and functional limitations.
Rehabilitation plays a critical role in postoperative recovery; however, optimal rehabilitation strategies following spinal fusion are not well established. Aquatic exercise has unique biomechanical advantages, including reduced axial loading, buoyancy-assisted movement, and increased resistance, which may facilitate earlier mobilization and neuromuscular reconditioning.
This study is a prospective comparative observational cohort study conducted at Tra Vinh General Hospital, Vietnam. A total of 124 patients undergoing thoracolumbar spinal fusion with pedicle screw instrumentation are included. Patients are allocated into two groups based on clinical recommendation and patient preference: a structured swimming-based rehabilitation group and a standard rehabilitation group.
The swimming-based rehabilitation program is initiated 6 to 8 weeks after surgery and consists of three sessions per week for 12 weeks. Each session includes warm-up exercises, low-impact swimming (primarily backstroke and freestyle), progressive endurance training, and cool-down exercises. Initial sessions are supervised to ensure safety and proper technique.
The standard rehabilitation group follows a conventional land-based program including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.
The primary outcome is the change in Oswestry Disability Index (ODI) from baseline to 12 weeks. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS) and quality of life assessed using the Short Form-36 (SF-36). Outcomes are assessed at baseline, 6 weeks, and 12 weeks.
Statistical analysis includes between-group comparisons using appropriate parametric or non-parametric tests and multivariate regression to adjust for baseline differences. Effect sizes are reported with 95% confidence intervals.
This study aims to evaluate whether structured swimming-based rehabilitation improves functional recovery, pain reduction, and quality of life compared with standard rehabilitation after thoracolumbar spinal fusion.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
Vinh Long
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Vĩnh Long、Vinh Long、ベトナム、890000
- Tra Vinh General Hospital
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients aged 18 years or older
- Patients undergoing thoracolumbar spinal fusion with pedicle screw instrumentation
- Patients able to participate in rehabilitation programs
- Patients who provide informed consent
Exclusion Criteria:
- Patients with severe neurological deficits preventing rehabilitation
- Patients with severe cardiopulmonary comorbidities contraindicating exercise
- Patients with postoperative complications requiring reoperation
- Patients unable to follow the rehabilitation protocol
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Swimming Rehabilitation
Patients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks.
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Structured aquatic exercise program initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks, including warm-up, swimming, and cool-down exercises.
|
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Standard Rehabilitation
Patients undergoing standard land-based postoperative rehabilitation including ambulation training, core strengthening, and flexibility exercises.
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Conventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
時間枠：Baseline to 12 weeks
|
The Oswestry Disability Index (ODI) assesses functional disability, with scores ranging from 0 to 100.
Higher scores indicate greater disability.
The outcome measure is the change in ODI from baseline to 12 weeks after initiation of rehabilitation.
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Baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
時間枠：Baseline to 12 weeks
|
Pain intensity is assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
The outcome measure is the change in VAS score from baseline to 12 weeks.
|
Baseline to 12 weeks
|
|
Quality of Life Measured by Short Form-36 (SF-36)
時間枠：Baseline to 12 weeks
|
Quality of life is assessed using the Short Form-36 (SF-36), with scores ranging from 0 to 100.
Higher scores indicate better health status.
The outcome measure is the change in SF-36 score from baseline to 12 weeks.
|
Baseline to 12 weeks
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Rainville J, Hartigan C, Martinez E, Limke J, Jouve C, Finno M. Exercise as a treatment for chronic low back pain. Spine J. 2004 Jan-Feb;4(1):106-15. doi: 10.1016/s1529-9430(03)00174-8.
- Waller B, Lambeck J, Daly D. Therapeutic aquatic exercise in the treatment of low back pain: a systematic review. Clin Rehabil. 2009 Jan;23(1):3-14. doi: 10.1177/0269215508097856.
- Mannion AF, Elfering A. Predictors of surgical outcome and their assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S93-108. doi: 10.1007/s00586-005-1045-9. Epub 2005 Dec 1.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TVGH-SWIM-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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